NCT07012395From ClinicalTrials.govRecruiting

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Spyre Therapeutics, Inc.
Enrolment target: 645
Started: 27 May 2025
Main results due: June 2027
Study sites: 271
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening
* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)
* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2

Exclusion Criteria:

* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
* Failed 4 or more approved or investigational advanced therapy classes

What this study is about

In the sponsor’s own words, from the registry.

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Study sites(271)

Site 024
Canoga Park, California, United States
Recruiting
Site 023
La Jolla, California, United States
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Site 012
Lancaster, California, United States
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Site 033
Colorado Springs, Colorado, United States
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Site 007
Kissimmee, Florida, United States
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029
Miami, Florida, United States
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Site 038
Chicago, Illinois, United States
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Site 006
Kansas City, Kansas, United States
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Site 030
Louisville, Kentucky, United States
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Site 035
Marrero, Louisiana, United States
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Site 011
Glen Burnie, Maryland, United States
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Site 003
Boston, Massachusetts, United States
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Site 028
Rochester, Minnesota, United States
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Site 037
New York, New York, United States
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040
Chapel Hill, North Carolina, United States
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Site 041
Durham, North Carolina, United States
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Site 016
Winston-Salem, North Carolina, United States
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Site 025
Providence, Rhode Island, United States
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Site 017
Kingsport, Tennessee, United States
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Site 013
Cedar Park, Texas, United States
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Site 005
Garland, Texas, United States
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Site 002
San Antonio, Texas, United States
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Site 008
Southlake, Texas, United States
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Site 009
Webster, Texas, United States
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Site 004
Seattle, Washington, United States
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Site 019
Tacoma, Washington, United States
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Site 105
La Plata, Buenos Aires, Argentina
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Site 102
Lujan de Cuyo, Mendoza Province, Argentina
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Site 103
Rosario, Sant Fe, Argentina
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Site 104
San Miguel de Tucumán, Tucumán Province, Argentina
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Site 201
Murdoch, Western Australia, Australia
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Site 208
Concord, Australia
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Site 202
Heidelberg, Australia
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Site 204
Liverpool, Australia
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Site 203
Melbourne, Australia
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Site 206
South Brisbane, Australia
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Site 207
Woolloongabba, Australia
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Site 463
Linz, Austria
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Site 476
Ghent, Osst-Vlaanderen, Belgium
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Site 474
Sint-Niklaas, Osst-Vlaanderen, Belgium
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Site 475
Bruges, Belgium
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Site 471
Ghent, Belgium
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Site 472
Roeselare, Belgium
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Site 481
Banja Luka, Bosnia and Herzegovina
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Site 484
Mostar, Bosnia and Herzegovina
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Site 483
Sarajevo, Bosnia and Herzegovina
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Site 123
Brasília, Federal District, Brazil
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Site 133
Goiânia, Goiás, Brazil
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Site 136
Juiz de Fora, Minas Gerais, Brazil
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Site 137
Teresina, Piauí, Brazil
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Site 125
Caxias do Sul, Rio Grande do Sul, Brazil
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Site 134
Passo Fundo, Rio Grande do Sul, Brazil
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Site 126
Passo Fundo, Rio Grande do Sul, Brazil
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Site 122
Porto Alegre, Rio Grande do Sul, Brazil
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Site 121
Porto Alegre, Rio Grande do Sul, Brazil
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Site 135
Barretos, São Paulo, Brazil
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Site 131
Campinas, São Paulo, Brazil
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Site 129
Consolação, São Paulo, Brazil
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Site 138
Jaú, São Paulo, Brazil
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Site 128
Santo André, São Paulo, Brazil
Recruiting

Showing 60 of 271 sites — filter to narrow it down. 271 of the 271 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07012395. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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